Title: Quality Engineer
Location: US-Michigan-Ann Arbor
· Deep involvement with CAPA investigations, corresponding root cause analysis, implementation of required actions, and follow-up verifications.
· Involved with analyzing Customer Complaints. Initiating and leading CAPAs where warranted.
· Participate in Internal Quality Audits.
· Work frequently with Manufacturing and Engineering to develop and document inspection methods and acceptance criteria for new and existing product launches, materials and suppliers.
· Responsible for documenting, investigating tracking, trending, and reporting product performance issues.
· Develop metrics to monitor processes and drive process improvement/corrective action.
· Assist Quality manager in maintaining the quality management systems.
· Interface with Engineering and Operations to ensure transfer to Production of new products are in accordance with approved data.
· Ensure timely resolution of supplier failures. Pursues supplier CAPAs where required.
· Knowledge of cGMP requirements including ISO13485, 21CFR 820 QSR, and other international regulations related to medical devices.
· Strong multi-tasking, analytical and problem solving skills.
· Knowledge of math and statistics. Ability to design experiments.
· Familiar with modern quality control techniques.
· Possess good technical writing and communication skills.
· Computer literacy with Microsoft Office products, LotusNotes, Great Plains, SAP and MiniTab.
· Bachelor of Science in engineering, science or related subject.
· Six Sigma certification is a plus.
· Professional certification is preferred (i.e. CQA-Certified Quality Auditor, CQE-Certified Quality Engineer, CSQE- Certified Software Quality Engineer, etc.).
WORK EXPERIENCE:Five years experience in Quality Assurance/Quality Systems.
Job: Quality Engineering